Device brand name · Electrode ph stomach

Bravo Ph Capsule Deliv Dev 1-Pk: medical device reports filed with FDA

155 reports name it, 2015–2017. Manufacturer given most often on reports: Given Israel. Product code FFT.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

155
device reports naming the brand: 0% of all MAUDE reports · about 14 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 89.7%
classified as malfunction: 92% across the product code; 0.6%
classified as death, as reported: 1 reports · not verified by FDA

FDA's MAUDE database holds 155 reports that name the brand "Bravo Ph Capsule Deliv Dev 1-Pk" (electrode ph stomach), received between September 2015 and March 2017; the manufacturer given most often on reports is Given Israel. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (89.7%), injury (9.7%) and death (0.6%); across all electrode, ph, stomach reports (product code FFT) death is recorded in 0.1% and malfunction in 92%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to adhere or bond (67.7%), communication or transmission problem (13.5%) and loss of or failure to bond (5.2%). The patient problems coded most often are chest pain, pain and death. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming Bravo Ph Capsule Deliv Dev 1-Pk was received in the five years to August 2026; the latest was received in March 2017.

By year received

Event type and report source

Event type, as classified on the report

Death0.6%1

Injury9.7%15

Malfunction89.7%139

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%155

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 12,898 reports carrying product code FFT. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Failure to adhere or bond	105	67.7%	44.7%
Communication or transmission problemthe device could not communicate or transmit	21	13.5%	1.3%
Loss of or failure to bond	8	5.2%	6.7%
Entrapment of device	3	1.9%	1%
High ph	3	1.9%	0.2%
Poor quality image	3	1.9%	0.1%
Connection problema connection problem	2	1.3%	0.6%
High readingsreadings were too high	2	1.3%	0%
Insufficient device problem information	2	1.3%	0.7%
Intermittent continuity	2	1.3%	0%
No display/image	2	1.3%	0.1%
Separation failure	2	1.3%	4.7%
Detachment of device component	1	0.6%	3.7%
Device operates differently than expectedthe device behaved unexpectedly	1	0.6%	2%
Failure to disconnect	1	0.6%	0.1%
False device output	1	0.6%	0%
Incorrect, inadequate or imprecise result or readings	1	0.6%	0%
Loss of data	1	0.6%	0.2%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Chest painchest pain	2	1.3%
Painpain, site not specified	2	1.3%
Deaththe patient died; cause not stated by this term	1	0.6%
Discomfortdiscomfort	1	0.6%
Dysphagia/ odynophagia	1	0.6%
Loss of vision	1	0.6%
Perforation	1	0.6%
Radiation exposure, unintended	1	0.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Bravo Ph Capsule Deliv Dev 1-Pk	Product code FFT	All MAUDE reports
Reports	155	12,898	26,136,888
Share of that pool	—	1.2%	0%
Classified as death, per 1,000 reports	6	1	9
Classified as injury	9.7%	7.5%	36.2%
Classified as malfunction	89.7%	92%	62.3%
Filed by the manufacturer	100%	95.8%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code FFT

Brand	Reports	Latest 12 months	Classified as death
Bravo	11,648	568	0%
Bravo Ph Capsule Delivery Device	372	0	0.3%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Bravo Ph Capsule Deliv Dev 1-Pk reports

How many FDA reports name Bravo Ph Capsule Deliv Dev 1-Pk?

155 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (89.7%), injury (9.7%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to adhere or bond (67.7%), communication or transmission problem (13.5%), loss of or failure to bond (5.2%), entrapment of device (1.9%) and high ph (1.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Bravo Ph Capsule Deliv Dev 1-Pk was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.